Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hand (mdph)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

fioravanti antonella, University of Siena

ClinicalTrials.gov Identifier:

NCT00773682

First received: October 15, 2008

Last updated: November 16, 2011

Last verified: September 2008

History of Changes

Purpose

Objective

To assess both the short-term and the long term effectiveness of spa therapy in patients with primary hand osteoarthritis (OA) in a single blind, prospective controlled, randomized trial.

Condition	Intervention	Phase
Osteoarthritis	Other: local mud-pack therapy and balneotherapy	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Efficacy and Tolerability of Mud Packs Therapy in Osteoarthritis of the Hands: a One Year Follow-up

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Further study details as provided by University of Siena:

Primary Outcome Measures:

Algofunctional state and quality of life [ Time Frame: two weeks, three , six, nine and twelve months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Consumption of symptomatic drugs and tolerability [ Time Frame: two weeks, three, six, nine and twelve months ] [ Designated as safety issue: Yes ]

Enrollment:	60
Study Start Date:	June 2008
Study Completion Date:	January 2010
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Patients will be treated with local mud-pack application on the hands for 20 minutes and thermal-mineral bath once a day for 15 days.

Detailed Description:

Osteoarthritis is the most common form of joint disease and a major contributor of disability in older people. Current treatment of OA include pharmacological and non-pharmacological modalities. Spa therapy has a long history in the treatment of OA, but few articles have evaluated the effectiveness of thermal treatment in patients with primary OA of the hands.

The aim of this study is to assess the duration of the clinical effectiveness of mud-packs application and mineral bath in patients with primary OA of the hands in a single blind, controlled, randomized trial.

Our study will follow the patients for a longer period of time (12 months) than was done in previous studies.

60 outpatients will be enrolled; 30 patients will be treated with a combination of daily local mud packs and mineral bath water from the spa centre of Fonteverde Natural Spa Resort (San Casciano Terme, Siena, Italy) for two weeks; 30 patients will continue regular, routine ambulatory care. Patients will be assessed at baseline time, after 2 weeks, after 3, 6, 9 and 12 months following the beginning of the study and will be evaluated by VAS for spontaneous pain, Dreiser Algofunctional index, HAQ, AIMS1 and symptomatic drugs consumption.

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients suffering from osteoarthritis of the hands according to the ACR criteria

Exclusion Criteria:

Patients suffering from any other rheumatological disease other than osteoarthritis
Patients that have been treated with mud-pack therapy and balneotherapy in the last 9 months
Contraindications to mud-packs and balneotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773682

Locations

Italy
Rheumatology Unit Azienda Ospedaliera Universitaria Senese
Siena, Italy, 53100

Sponsors and Collaborators

University of Siena

Investigators

Principal Investigator:

Antonella Fioravanti, md

Rheumatology Unit- Azienda Ospedaliera Universitaria Senese-siena

More Information

Publications:

Fioravanti A, Perpignano G, Tirri G, Cardinale G, Gianniti C, Lanza CE, Loi A, Tirri E, Sfriso P, Cozzi F. Effects of mud-bath treatment on fibromyalgia patients: a randomized clinical trial. Rheumatol Int. 2007 Oct;27(12):1157-61. Epub 2007 May 23.

Cantarini L, Leo G, Giannitti C, Cevenini G, Barberini P, Fioravanti A. Therapeutic effect of spa therapy and short wave therapy in knee osteoarthritis: a randomized, single blind, controlled trial. Rheumatol Int. 2007 Apr;27(6):523-9. Epub 2006 Nov 15.

Fioravanti A, Valenti M, Altobelli E, Di Orio F, Nappi G, Crisanti A, Cantarini L, Marcolongo R. Clinical efficacy and cost-effectiveness evidence of spa therapy in osteoarthritis. The results of "Naiade" Italian Project. Panminerva Med. 2003 Sep;45(3):211-7.

Responsible Party:	fioravanti antonella, medical doctor, University of Siena
ClinicalTrials.gov Identifier:	NCT00773682 History of Changes
Other Study ID Numbers:	339/07
Study First Received:	October 15, 2008
Last Updated:	November 16, 2011
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Siena:

osteoarthritis
hands
mud-packs therapy
balneotherapy
Osteoarthritis of the hands

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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